NCT01239654

Brief Summary

It is an exploratory study evaluating a biological effect (stent strut coverage) using a novel technology such as OCT without any clinical implication.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2010

Shorter than P25 for phase_3

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 11, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

May 23, 2012

Status Verified

May 1, 2012

Enrollment Period

11 months

First QC Date

November 10, 2010

Last Update Submit

May 22, 2012

Conditions

Acute Coronary Syndrome

Keywords

acutecoronarysyndromeeverolimuszotarolimusopticalcoherencetomography

Outcome Measures

Primary Outcomes (1)

  • Evaluate the completeness of neointimal coverage following stent implantation (everolimus vs. zotarolimus-eluting stent) in patients with ACS.

    Evaluate the completeness of neointimal coverage following stent implantation (everolimus vs. zotarolimus-eluting stent) in patients with ACS. The degree of neointimal coverage will be assessed using optical coherence tomography (OCT) calculating the rate of exposed stent struts in the study stents.

    6 month

Study Arms (2)

everolimus

ACTIVE COMPARATOR

everolimus-eluting stent

Device: stent implantation

zotarolimus

ACTIVE COMPARATOR

zotarolimus-eluting stent

Device: stent implantation

Interventions

stent implantationDEVICE

implantation of everolimus-eluting stent vs zotarolimus-eluting stent

everolimuszotarolimus

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of ACS and clinical indication to PCI
  • Presence of 1 or more de novo stenosis equal or greater than 70% in native coronary arteries.
  • Patient is \> 18 years of age (or minimum age as required by local regulations).
  • The patient has consented to participate by signing the "Patient Informed Consent Form".
  • The patient is willing and able to cooperate with study procedures and required follow up visits.

You may not qualify if:

  • No other stent implanted before in the target lesion
  • Patients treated for lesions in venous or arterial grafts.
  • Patients treated for in-stent restenosis.
  • Patients treated for Unprotected Left Main lesions.
  • Patients with left ventricular ejection fraction (LVEF) ≤30%.
  • Patients with chronic kidney disease (creatinine ≥1.5 mg/dL) .
  • Women with known pregnancy or who are lactating.
  • Patients with hypersensitivity or allergies to heparin, drugs such as ABT-578 and everolimus, or any other analogue or derivative, cobalt, chromium, nickel, molybdenum or contrast media.
  • Contraindication to the use of clopidogrel and/or ASA:
  • History of drug allergy to thienopyridine derivatives or ASA;
  • History of clinically significant or persistent thrombocytopenia or neutropenia
  • Active bleeding or significant risk of bleedings, severe hepatic insufficiency, current peptic ulceration, proliferative diabetic retinopathy.
  • Current medical condition with a life expectancy of less than 24 months.
  • The subject is participating in another device or drug study. Subject must have completed the follow-up phase of any previous study at least 30 days prior to enrolment in this trial.
  • Patients with medical conditions that preclude the follow-up as defined in the protocol or that otherwise limits participation in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Università della Magna Grecia

Catanzaro, 88100, Italy

Location

Careggi Hospital

Florence, 50134, Italy

Location

San Raffaele Hospital

Milan, 20132, Italy

Location

Ospedale Civile di Mirano

Mirano, 30035, Italy

Location

Related Publications (6)

  • Barlis P, Regar E, Serruys PW, Dimopoulos K, van der Giessen WJ, van Geuns RJ, Ferrante G, Wandel S, Windecker S, van Es GA, Eerdmans P, Juni P, di Mario C. An optical coherence tomography study of a biodegradable vs. durable polymer-coated limus-eluting stent: a LEADERS trial sub-study. Eur Heart J. 2010 Jan;31(2):165-76. doi: 10.1093/eurheartj/ehp480. Epub 2009 Nov 4.

    PMID: 19889649BACKGROUND

  • Xie Y, Takano M, Murakami D, Yamamoto M, Okamatsu K, Inami S, Seimiya K, Ohba T, Seino Y, Mizuno K. Comparison of neointimal coverage by optical coherence tomography of a sirolimus-eluting stent versus a bare-metal stent three months after implantation. Am J Cardiol. 2008 Jul 1;102(1):27-31. doi: 10.1016/j.amjcard.2008.02.091. Epub 2008 Apr 25.

    PMID: 18572031BACKGROUND

  • Matsumoto D, Shite J, Shinke T, Otake H, Tanino Y, Ogasawara D, Sawada T, Paredes OL, Hirata K, Yokoyama M. Neointimal coverage of sirolimus-eluting stents at 6-month follow-up: evaluated by optical coherence tomography. Eur Heart J. 2007 Apr;28(8):961-7. doi: 10.1093/eurheartj/ehl413. Epub 2006 Nov 29.

    PMID: 17135281BACKGROUND

  • Tahara S, Bezerra HG, Sirbu V, Kyono H, Musumeci G, Rosenthal N, Guagliumi G, Costa MA. Angiographic, IVUS and OCT evaluation of the long-term impact of coronary disease severity at the site of overlapping drug-eluting and bare metal stents: a substudy of the ODESSA trial. Heart. 2010 Oct;96(19):1574-8. doi: 10.1136/hrt.2009.188037. Epub 2010 Aug 23.

    PMID: 20736206BACKGROUND

  • Guagliumi G, Sirbu V, Bezerra H, Biondi-Zoccai G, Fiocca L, Musumeci G, Matiashvili A, Lortkipanidze N, Tahara S, Valsecchi O, Costa M. Strut coverage and vessel wall response to zotarolimus-eluting and bare-metal stents implanted in patients with ST-segment elevation myocardial infarction: the OCTAMI (Optical Coherence Tomography in Acute Myocardial Infarction) Study. JACC Cardiovasc Interv. 2010 Jun;3(6):680-7. doi: 10.1016/j.jcin.2010.04.005.

    PMID: 20630463BACKGROUND

  • Chieffo A, Buchanan GL, Parodi G, Versaci F, Bianchi RM, Valenti R, Sacca S, Mongiardo A, Span S, Migliorini A, Spaccarotella C, Reimers B, Antoniucci D, Indolfi C, Ferrari A, Maehara A, Mintz GS, Colombo A. Drug-eluting stent implantation in patients with acute coronary syndrome - the Activity of Platelets after Inhibition and Cardiovascular Events: Optical Coherence Tomography (APICE OCT) study. EuroIntervention. 2014 Dec;10(8):916-23. doi: 10.4244/EIJY14M06_10.

    PMID: 24974806DERIVED

MeSH Terms

Conditions

Acute Coronary SyndromeSyndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesDiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Antonio Colombo, MD

    IRCCS San Raffaele

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Invasive Cardiology

Study Record Dates

First Submitted

November 10, 2010

First Posted

November 11, 2010

Study Start

September 1, 2010

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

May 23, 2012

Record last verified: 2012-05

Locations

IT(4)